Pharmaceuticals and Biotechnology – Regulatory Specialist

Hogan Lovells • Washington DC, DC

5d

About The Position

Hogan Lovells Cadwalader is seeking a Regulatory Specialist to join its Global Pharmaceutical and Biotechnology practice. The practice supports companies throughout the product lifecycle, including manufacturing, compliance, and post-market oversight. The position focuses on FDA-regulated drug and biologic manufacturing, particularly Current Good Manufacturing Practice (CGMP) requirements, and provides an opportunity to address complex manufacturing and quality challenges. The role may be based remotely or in a hybrid arrangement, depending on the candidate’s preference and proximity to firm offices, and requires at least 25% travel, including international travel.

The specialist will advise clients on CGMP compliance, inspection readiness, remediation, quality systems, and regulatory enforcement matters. They will assess facilities, processes, and documentation; help clients prepare for and respond to FDA inspections; and collaborate with cross-functional teams. Candidates should bring substantial FDA inspection experience, strong knowledge of pharmaceutical manufacturing regulations and quality systems, excellent communication skills, and the ability to manage complex projects. Salary is commensurate with experience. The role is eligible for additional compensation, which may include annual performance and discretionary bonuses, and firm benefits subject to applicable plan terms.

Requirements

• Bachelor’s, MS, or PhD degree in a relevant scientific or engineering discipline, such as pharmaceutical sciences, chemistry, microbiology, or chemical or biomedical engineering.
• At least 5 years of experience as an FDA Investigator, including direct experience conducting inspections of drug and/or biologics manufacturing facilities.
• Deep knowledge of FDA CGMP regulations, inspection processes, and enforcement actions related to pharmaceutical manufacturing.
• Strong understanding of quality systems, including CAPA, deviation management, validation, and data integrity principles.
• Experience reviewing manufacturing operations, laboratory controls, and quality assurance systems.
• Familiarity with FDA regulatory submission requirements for CMC (Chemistry, Manufacturing, and Controls) sections.
• Excellent written and verbal communication skills, including the ability to clearly explain complex regulatory requirements.
• Ability to collaborate with multidisciplinary teams across functional areas and jurisdictions.
• Willingness and ability to travel at least 25% of the time, including internationally.
• Strong attention to detail, proactive problem-solving skills, and ability to manage multiple complex projects in a fast-paced environment.

Nice To Haves

• Candidates may include a cover letter and school transcript or equivalent with their application.
• Relocation may be available as an additional benefit.

Responsibilities

• Provide expert guidance on FDA CGMP requirements for drug and biologic manufacturing, including 21 CFR Parts 211, 212, and 600.
• Advise clients on FDA regulatory compliance, inspection readiness, and post-inspection remediation, including conducting mock FDA inspections.
• Assess manufacturing facilities, quality systems, and documentation to identify compliance risks and recommend corrective and preventive actions (CAPAs).
• Support responses to FDA inspectional observations (Form FDA 483s), Warning Letters, regulatory meetings, and other enforcement actions.
• Assist with developing and revising quality systems documentation, including SOPs, batch records, deviation investigations, and validation protocols.
• Work with client cross-functional teams, including Quality Assurance, Manufacturing, Regulatory Affairs, and Engineering, to support compliance across operations.
• Provide strategic advice during FDA inspections and participate in inspection preparation and mock audits as appropriate.
• Advise on data integrity, contamination control, process validation, equipment qualification, and supplier quality management.
• Monitor evolving FDA policies, guidance documents, and enforcement trends related to CGMP compliance.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Paid time off
• Additional benefits may include relocation
• Additional compensation may include annual performance bonuses and discretionary bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior